Microbial ColonizationBABYCARENCT05524649
Effect of Probiotics on Infant's Fecal Microbiota Composition
A study testing Food Supplement 1 and Food Supplement 2 in people with Microbial Colonization, run by AB Biotics, SA at 2 sites in 2 countries.
Trial summary
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Read more about this study
- Who is it for?
- Ages 1 day to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Food Supplement 1 and Food Supplement 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants
- Age between 1 and 90 days
- Gestational age between 37 and 42 weeks
- Appropiate birth weight for gestational age (between P10 and P90)
- APGAR test score for birth normal at 1' and 5' of 7-10
- Whose parents accept the follow-up of the study procedures and sign the informed consent
Who cannot join
- Infants participating in other clinical study
- Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
- Infants who have taken antibiotics 4 weeks prior the start study
- Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
- Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
- Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
Show all 9Show fewer
- TORCH complex infections
- Every other diseases related with the immune system
- Parents who can not accomplish the follow-up of the study (medical criterium)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mexico1 site, 1 recruiting
- Not yet recruiting
Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
Alcaldía Coyoacán, Puebla, 04530
José Francisco González Dr., 55 74317715 ext. +52, jf.gonzalezzamora@gmail.com
Spain1 site, 1 recruiting
- Recruiting
Clínica Viamed Montecanal
Zaragoza, Aragon, 50012
Gerardo Rodríguez Martínez, MD, 654633910 ext. +34, gerard@unizar.es
About this study
Official title: Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Read the detailed description
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.
- Conditions
- Microbial Colonization
- Being tested
- Food Supplement 1, Food Supplement 2, Placebo
- Keywords
- Probiotics, Infants, Microbiota
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Supplement 1Dietary supplement
Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day
Food Supplement 2Dietary supplement
Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day
PlaceboDietary supplement
5 drops/day for 3 months of sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority. Receives: Dietary Supplement: Food Supplement 1 |
| Experimental 2 | Experimental | Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority. Receives: Dietary Supplement: Food Supplement 2 |
| Placebo | Placebo comparator | Sunflower oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
Measured: day 0, month 3
Secondary outcomes (15)
Weight change
Change in weight (g per day) between day 0 and month 3
Measured: day 0, month 1, month 2, month 3
Length change
Change in length (cm) between day 0 and month 3
Measured: day 0, month 1, month 2, month 3
Head circumference change
Change in head circumference (cm) between day 0 and month 3
Measured: day 0, month 1, month 2, month 3
BMI change
Change in BMI (kg/m2) between day 0 and month 3
Measured: day 0, month 1, month 2, month 3
Frequency of depositions
Frequency of depositions (number stools/day) documented in participants diary
Measured: day 0, month 1, month 2, month 3
Consistency of stools
Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid
Measured: day 0, month 1, month 2, month 3
Infant colic
Incidence of infant colic, defined as prolonged and recurrent periods of crying, agitation, or irritability without apparent cause that cannot be prevented or resolved by your caregivers, for three or more hours daily for three or more days a week
Measured: day 0, month 1, month 2, month 3
Vomiting
Incidence of vomiting (n/day)
Measured: day 0, month 1, month 2, month 3
Sleeping habits
Nocturnal sleeping (min/day), total sleeping hours (min/day)
Measured: day 0, month 1, month 2, month 3
Incidence of infections
Number and duration (in days) of any type of infectious episodes
Measured: day 0, month 1, month 2, month 3
Fever
Number of days with fever (axial body temperature higher than 37.5 ºC)
Measured: day 0, month 1, month 2, month 3
Antibiotics
Number of days with antibiotic treatment
Measured: day 0, month 1, month 2, month 3
Change in fecal microbiota composition
Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing
Measured: day 0, month 3
sIgA in stool samples
Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA
Measured: day 0, month 3
Calprotectin
Analysis of fecal calprotectin through ELISA
Measured: day 0, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Jun 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled trial in 120 healthy infants between 1 and 90 days of age, who will be allocated to receive either one of the probiotic strains or placebo for 3 months
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524649
- Sponsor's protocol ID
- AB-BABYCARE-21
- Acronym
- BABYCARE
- Status last verified
- Oct 2024
- First submitted
- 26 Aug 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen K, Liu C, Li H, Lei Y, Zeng C, Xu S, Li J, Savino F. Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Pediatr. 2021 Sep 10;9:635176. doi: 10.3389/fped.2021.635176. eCollection 2021.
PubMed 34568236Braegger C, Chmielewska A, Decsi T, Kolacek S, Mihatsch W, Moreno L, Piescik M, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2011 Feb;52(2):238-50. doi: 10.1097/MPG.0b013e3181fb9e80.
PubMed 21150647Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
PubMed 32727119Castanet M, Costalos C, Haiden N, Hascoet JM, Berger B, Sprenger N, Grathwohl D, Brussow H, De Groot N, Steenhout P, Pecquet S, Benyacoub J, Picaud JC. Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial. Nutrients. 2020 May 20;12(5):1481. doi: 10.3390/nu12051481.
PubMed 32443684Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
PubMed 26832746Radke M, Picaud JC, Loui A, Cambonie G, Faas D, Lafeber HN, de Groot N, Pecquet SS, Steenhout PG, Hascoet JM. Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial. Pediatr Res. 2017 Apr;81(4):622-631. doi: 10.1038/pr.2016.270. Epub 2016 Dec 21.
PubMed 28002391
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
- ClinicalTrials.gov ID
- NCT05524649
- Acronym / sponsor ID
- BABYCARE / AB-BABYCARE-21
- Conditions
- Microbial Colonization
- Keywords
- Probiotics, Infants, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Detailed description
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomized, placebo-controlled trial in 120 healthy infants between 1 and 90 days of age, who will be allocated to receive either one of the probiotic strains or placebo for 3 months
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Dietary Supplement: Food Supplement 1Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority. |
| Experimental 2 | Experimental | Dietary Supplement: Food Supplement 2Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSunflower oil |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy infants
- Age between 1 and 90 days
- Gestational age between 37 and 42 weeks
- Appropiate birth weight for gestational age (between P10 and P90)
- APGAR test score for birth normal at 1' and 5' of 7-10
Key exclusion criteria (9 listed)
- Infants participating in other clinical study
- Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
- Infants who have taken antibiotics 4 weeks prior the start study
- Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
- Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Supplement 1Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day | Dietary supplement | Experimental 1 |
| Food Supplement 2Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day | Dietary supplement | Experimental 2 |
| Placebo5 drops/day for 3 months of sunflower oil | Dietary supplement | Placebo |
Primary outcome
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
Time frame: day 0, month 3
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
15 secondary outcomes
Weight change
Time frame: day 0, month 1, month 2, month 3
Length change
Time frame: day 0, month 1, month 2, month 3
Head circumference change
Time frame: day 0, month 1, month 2, month 3
BMI change
Time frame: day 0, month 1, month 2, month 3
Frequency of depositions
Time frame: day 0, month 1, month 2, month 3
Consistency of stools
Time frame: day 0, month 1, month 2, month 3
Infant colic
Time frame: day 0, month 1, month 2, month 3
Vomiting
Time frame: day 0, month 1, month 2, month 3
Sleeping habits
Time frame: day 0, month 1, month 2, month 3
Incidence of infections
Time frame: day 0, month 1, month 2, month 3
Fever
Time frame: day 0, month 1, month 2, month 3
Antibiotics
Time frame: day 0, month 1, month 2, month 3
Change in fecal microbiota composition
Time frame: day 0, month 3
sIgA in stool samples
Time frame: day 0, month 3
Calprotectin
Time frame: day 0, month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 34568236Chen K, Liu C, Li H, Lei Y, Zeng C, Xu S, Li J, Savino F. Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Pediatr. 2021 Sep 10;9:635176. doi: 10.3389/fped.2021.635176. eCollection 2021.
- Background: PubMed 21150647Braegger C, Chmielewska A, Decsi T, Kolacek S, Mihatsch W, Moreno L, Piescik M, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2011 Feb;52(2):238-50. doi: 10.1097/MPG.0b013e3181fb9e80.
- Background: PubMed 32727119Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243.
- Results publication: PubMed 32443684Castanet M, Costalos C, Haiden N, Hascoet JM, Berger B, Sprenger N, Grathwohl D, Brussow H, De Groot N, Steenhout P, Pecquet S, Benyacoub J, Picaud JC. Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial. Nutrients. 2020 May 20;12(5):1481. doi: 10.3390/nu12051481.
- Results publication: PubMed 26832746Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
- Results publication: PubMed 28002391Radke M, Picaud JC, Loui A, Cambonie G, Faas D, Lafeber HN, de Groot N, Pecquet SS, Steenhout PG, Hascoet JM. Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial. Pediatr Res. 2017 Apr;81(4):622-631. doi: 10.1038/pr.2016.270. Epub 2016 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement 1 and Food Supplement 2 in people with Microbial Colonization, run by AB Biotics, SA at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerardo Rodríguez Martínez, MD (654633910 ext. +34, gerard@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces (time frame: day 0, month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05524649, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.